# FDA 483 - BOEHRINGER INGELHEIM PROMECO S.A. de C.V. - December 06, 2019

Source: https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-promeco-sa-de-cv/6509628e-7695-4939-85b1-d7a6305db4ed

> FDA 483 for BOEHRINGER INGELHEIM PROMECO S.A. de C.V. on December 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BOEHRINGER INGELHEIM PROMECO S.A. de C.V.
- Inspection Date: 2019-12-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Boehringer Ingelheim Promeco S.A de C.V. in Xochimilco, Mexico City, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate discrepancies, submit timely Field Alert Reports for out-of-specification results, and conduct stability studies in a timely manner. These issues indicate a lack of robust quality oversight and compliance with regulatory requirements.

## Related Documents

- [483 - 2022-05-20](https://www.globalkeysolutions.net/records/483/boehringer-ingelheim-promeco-sa-de-cv/52e1f5b4-75f5-401b-81cd-27e099cb3453)

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.globalkeysolutions.net/companies/boehringer-ingelheim-promeco-sa-de-cv/d1f077c2-d2d3-4a71-b897-7595adbb343b

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1